Recon: Pfizer to increase COVID-19 antiviral output with French deal; Unilever signals pursuit of GSK consumer arm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA advises physicians to consider alternatives to Endologix AFX2 endovascular grafts (MedTech Dive)
- Moderna CEO says data for Omicron-specific shot likely available in March (Reuters)
- Martin Shkreli is ordered to pay $64 million and is banned from the pharma industry for life (STAT) (Washington Post)
- A $3B+ peak sales win? Pfizer thinks so, as FDA offers a tardy green light to its JAK1 drug abrocitinib (Endpoints)
- Global vaccine-sharing programme reaches milestone of 1 billion doses (Reuters)
- WHO recommends two new drugs to treat COVID-19 (WHO)
- Return of the flu: EU faces threat of prolonged 'twindemic' (Reuters)
- Unilever Pursues Glaxo and Pfizer Consumer Health Venture (NYTimes) (Reuters 1, 2) (Scrip)
- Pfizer to boost COVID-19 pill production with French deal (Reuters)
- Canada approves Pfizer's COVID-19 oral antiviral treatment for adults (Reuters)
- Europe preps for the launch of its new clinical trials database, with a push to increase trial participation (Endpoints)
- EU New Drug Approvals Hit Record High (Pink Sheet)
- India's Gennova developing Omicron-specific COVID-19 vaccine (Reuters)
- 2021 Saw India Enable Accelerated Regulatory Pathways – Can It Become The Norm? (Pink Sheet)
- Biden Pledges A Billion COVID-19 Tests, Announces Plan Requiring Private Insurers To Pay For At-Home Diagnostics (MedTech Intelligence)
- Biden administration to buy 500M more rapid COVID-19 tests to give free to Americans (MedTech Dive)
- For Coronavirus Testing, the Nose May Not Always Be Best (NYT)
- Analysis: CDC Grapples With Rapidly Evolving Virus and Imperfect Data (NYT)
- French parliament approves vaccine pass (Reuters)
- Israeli study shows 4th shot of COVID-19 vaccine less effective on Omicron (Reuters)
- Analysis: China's 'zero-COVID' campaign under strain as Omicron surges (Reuters)
- UK's Johnson plans to scrap COVID-19 self-isolation law - The Telegraph (Reuters)
- Australia PM blames Omicron for testing woes as COVID-19 cases hit downward trend (Reuters)
- Nepal starts giving COVID-19 vaccine booster shots (Reuters)
- Pfizer And Abbvie JAKs Finally Join Dupixent In US Dermatitus Space (Scrip)
- After nabbing two AI-generated molecules, AstraZeneca returns to BenevolentAI with new collaboration (Endpoints)
- First Academic Sponsor On EMA’s PRIME Pledges Cheaper CAR-Ts (Pink Sheet)
- Vir expands partnership with Gates Foundation, adding $50M for HIV and malaria antibody research initiative (Endpoints)
- Biopharma dealmakers reflect on last year’s shifts in the market, as they gear up for another ‘active’ year ahead (Endpoints)
- ‘Challenges Ahead’ For Cell And Gene Therapy, Notes Catapult’s New Chairman McCubbin (Pink Sheet)
- JPM22 - The gene editing revolution: Now it's time for human data to define a fast-changing field (Endpoints)
- Scientists are making CAR-T cells more clever. Here’s what the next generation could look like (STAT)
- Strong new evidence suggests a virus triggers multiple sclerosis (STAT)
- Exclusive: Biogen leaders warn sales teams: Only 2,000 patients might access Aduhelm over the next several years (Endpoints)
- FDA, Industry To Miss MDUFA V Congressional Deadline; Insiders At Odds Over Future Of Deal (MedTech Intelligence)
- FDA No Longer Publishing Quarterly PMA And HDE Decisions (MedTech Intelligence)
- MHRA's Graeme Tunbridge Joins BSI Notified Body (MedTech Intelligence)
- J&J, New Mexico Ink $44M Opioid Settlement (Law360)
- 5 Questions After High Court Smacks Down Vax-Or-Test Rule (Law360)
- Hospitals Confront the Fallout From Supreme Court Ruling on Vaccine Mandate (NYT)
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